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Clinical Trials/ACTRN12621000203853
ACTRN12621000203853
Recruiting
N/A

Pilot Study assessing blood flow changes in patients with hypertensive heart failure fitted with an Extra Aortic Counterpulsation Device (BioQ CA) acutely attached to the ascending aorta in the open chest

BIOQ DEVICES PTY LTD0 sites40 target enrollmentFebruary 26, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiovascular
Sponsor
BIOQ DEVICES PTY LTD
Enrollment
40
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 26, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
BIOQ DEVICES PTY LTD

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria will include
  • Adults of 18 years or over
  • Patient has read and signed the informed consent prior to study related procedures
  • Willing and able to comply with all required follow\-up evaluations and assessments
  • Patients scheduled for Coronary Artery Bypass Grafting (CABG) will be assessed for:
  • 1\) hypertension and ejection fraction (EF) cut\-offs defined below,
  • 2\) Presence of heart failure ( Class I to IV),
  • 3\) coronary artery disease,
  • 4\) aortic stiffness,
  • 5\) stroke risk,

Exclusion Criteria

  • Exclusion criteria will include:
  • history of previous stroke,
  • significant mitral and or aortic valve disease/dysfunction,
  • ascending aortic disease calcification or atherosclerosis or aneurysm.
  • intraoperative echo or epi\-aortic ultrasound will be used during the surgical procedures to exclude or confirm presence of severe aortic disease before applying the device as a final precautionary measure prior to placement. Patients will be excluded at this point if they are confirmed in the exclusion criteria.

Outcomes

Primary Outcomes

Not specified

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